1.Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue(first to third batches)
Xiao-fei SI ; Gui-xia SUN ; Bao-mei ZHANG ; Tian-xing DAI ; Yan-xiu GE ; Dian-zhuo JIANG
The Chinese Journal of Clinical Pharmacology 2025;41(1):143-148
To meet the domestic clinical demand timely,the national health commission has released three batches of encourage generic drug catalogues,which plays a good guiding role in improving the supply level and accessibility of generic drugs.Based on literature investigation,the typical cases of novel pharmaceutical preparations were analyzed,and the pharmaceutical considerations were put forward in terms formulation,manufacturing process and quality control,aimed to provide scientific reference for research and development of such drugs.
2.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
3.ACTH-independent Cushing′s syndrome caused by a GNAS hotspot mutation: Case reports of two rare patients with McCune-Albright syndrome complicated by Cushing′s syndrome and literature review
Ziwei CHEN ; Congcong XIA ; Ning PAN ; Zhuozhou CUI ; Li JIANG ; Ni ZHEN ; Yuan XIAO ; Zhiya DONG ; Xiaoyu MA ; Wenli LU
Chinese Journal of Endocrinology and Metabolism 2025;41(6):497-504
McCune-Albright syndrome(MAS) is a postzygotic somatic mutation disorder caused by activating mutations in the GNAS gene, which encodes the α subunit of the stimulatory G protein. Its clinical features typically include polyostotic fibrous dysplasia, cafe-au-lait skin pigmentation, and endocrine hyperactivity, such as Cushing′s syndrome, hyperthyroidism, and growth hormone excess. Here, we report two rare cases of MAS complicated with adrenocorticotropic hormone(ACTH)-independent Cushing syndrome, and provide a review and analysis of previously reported MAS cases associated with Cushing′s syndrome.
4.Shaoyaotang Restores Th17/Treg Cell Balance by Regulating Glucose Metabolism Reprogramming in Treatment of Ulcerative Colitis
Yiwen WANG ; Yiling XIA ; Erle LIU ; Shaijin JIANG ; Bo ZOU ; Dongsheng WU ; Youwei XIAO ; Hui CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):78-85
ObjectiveTo investigate the effect of Shaoyaotang on T helper cell 17/regulatory T lymphocyte(Th17/Treg) cell balance in ulcerative colitis and decipher the intervention mechanism based on glucose metabolism reprogramming. MethodsThe mouse model of ulcerative colitis was established by the dextran sulfate sodium (DSS) method. Forty-eight C57BL/6 mice were randomly allocated into normal, model, Western drug control (mesalazine, 0.39 g·kg-1·d-1), Shaoyaotang (15.54 g·kg-1·d-1), inhibitor (2-deoxy-D-glucose, 2-DG, 100 mg·kg-1·d-1), and inhibitor (2-DG, 100 mg·kg-1·d-1) + Shaoyaotang (15.54 g·kg-1·d-1) groups. Mice were administrated with the corresponding drugs by gavage for 7 days. The general conditions and the colon injury degree were observed 24 h after the last administration. The expression of interleukin (IL)-10 and IL-17 in the colon tissue was detected by immunohistochemical staining. Western blot and Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) were performed to determine the protein and mRNA levels, respectively, of hypoxia-inducing factor-1α (HIF-1α), lactate dehydrogenase (LDHA), and hexokinase 2 (HK2) in the colon tissue. Th17/Treg cell differentiation was detected by flow cytometry. Enzyme-linked immunosorbent assay was employed to measure the levels of lactic acid and glucose in the colon tissue and IL-10, IL-17, and IL-6 in the serum. ResultsCompared with the normal group, the model group showed decreases in body weight and disease activity index (DAI) (P<0.05), elevations in levels of HIF-1α, LDHA, HK2, IL-17, IL-6, Th17 cells, lactic acid, and glucose in the colon tissue (P<0.05), and declines in the levels of of IL-10 and Treg cells (P<0.05). Compared with the model group, the drug administration groups showed increases in body weight and DAI (P<0.05), declines in levels of HIF-1α, LDHA, HK2, IL-17, IL-6, Th17 cells, lactic acid, and glucose in the colon tissue (P<0.05), and rises in levels of IL-10 and Treg cells (P<0.05). Shaoyaotang+2-DG group had the most obvious effect. ConclusionShaoyaotang can relieve diarrhea and bloody stool in mice with ulcerative colitis by restoring the Th17/Treg cell balance via regulation of glucose metabolism reprogramming, thus playing a role in the treatment of ulcerative colitis.
5.Shaoyaotang Restores Th17/Treg Cell Balance by Regulating Glucose Metabolism Reprogramming in Treatment of Ulcerative Colitis
Yiwen WANG ; Yiling XIA ; Erle LIU ; Shaijin JIANG ; Bo ZOU ; Dongsheng WU ; Youwei XIAO ; Hui CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):78-85
ObjectiveTo investigate the effect of Shaoyaotang on T helper cell 17/regulatory T lymphocyte(Th17/Treg) cell balance in ulcerative colitis and decipher the intervention mechanism based on glucose metabolism reprogramming. MethodsThe mouse model of ulcerative colitis was established by the dextran sulfate sodium (DSS) method. Forty-eight C57BL/6 mice were randomly allocated into normal, model, Western drug control (mesalazine, 0.39 g·kg-1·d-1), Shaoyaotang (15.54 g·kg-1·d-1), inhibitor (2-deoxy-D-glucose, 2-DG, 100 mg·kg-1·d-1), and inhibitor (2-DG, 100 mg·kg-1·d-1) + Shaoyaotang (15.54 g·kg-1·d-1) groups. Mice were administrated with the corresponding drugs by gavage for 7 days. The general conditions and the colon injury degree were observed 24 h after the last administration. The expression of interleukin (IL)-10 and IL-17 in the colon tissue was detected by immunohistochemical staining. Western blot and Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) were performed to determine the protein and mRNA levels, respectively, of hypoxia-inducing factor-1α (HIF-1α), lactate dehydrogenase (LDHA), and hexokinase 2 (HK2) in the colon tissue. Th17/Treg cell differentiation was detected by flow cytometry. Enzyme-linked immunosorbent assay was employed to measure the levels of lactic acid and glucose in the colon tissue and IL-10, IL-17, and IL-6 in the serum. ResultsCompared with the normal group, the model group showed decreases in body weight and disease activity index (DAI) (P<0.05), elevations in levels of HIF-1α, LDHA, HK2, IL-17, IL-6, Th17 cells, lactic acid, and glucose in the colon tissue (P<0.05), and declines in the levels of of IL-10 and Treg cells (P<0.05). Compared with the model group, the drug administration groups showed increases in body weight and DAI (P<0.05), declines in levels of HIF-1α, LDHA, HK2, IL-17, IL-6, Th17 cells, lactic acid, and glucose in the colon tissue (P<0.05), and rises in levels of IL-10 and Treg cells (P<0.05). Shaoyaotang+2-DG group had the most obvious effect. ConclusionShaoyaotang can relieve diarrhea and bloody stool in mice with ulcerative colitis by restoring the Th17/Treg cell balance via regulation of glucose metabolism reprogramming, thus playing a role in the treatment of ulcerative colitis.
6.Liuwei Dihuang Pills improve chemotherapy-induced ovarian injury in mice by promoting the proliferation of female germline stem cells.
Bo JIANG ; Wen-Yan ZHANG ; Guang-di LIN ; Xiao-Qing MA ; Guo-Xia LAN ; Jia-Wen ZHONG ; Ling QIN ; Jia-Li MAI ; Xiao-Rong LI
China Journal of Chinese Materia Medica 2025;50(9):2495-2504
This study primarily investigates the effect of Liuwei Dihuang Pills on the activation and proliferation of female germline stem cells(FGSCs) in the ovaries and cortex of mice with premature ovarian failure(POF), and how it improves ovarian function. ICR mice were randomly divided into the control group, model group, Liuwei Dihuang Pills group, Liuwei Dihuang Pills double-dose group, and estradiol valerate group. A mouse model of POF was established by intraperitoneal injection of cyclophosphamide. After successful modeling, the mice were treated with Liuwei Dihuang Pills or estradiol valerate for 28 days. Vaginal smears were prepared to observe the estrous cycle and body weight. After the last administration, mice were sacrificed and sampled. Serum levels of estradiol(E_2), follicle-stimulating hormone(FSH), luteinizing hormone(LH), and anti-Müllerian hormone(AMH) were measured by enzyme-linked immunosorbent assay(ELISA). Hematoxylin-eosin(HE) staining was used to observe ovarian morphology and to count follicles at all stages to evaluate ovarian function. Immunohistochemistry was used to detect the expression of mouse vasa homolog(MVH), a marker of ovarian FGSCs. Immunofluorescence staining, using co-labeling of MVH and proliferating cell nuclear antigen(PCNA), was used to detect the expression and localization of specific markers of FGSCs. Western blot was employed to assess the protein expression of MVH, octamer-binding transcription factor 4(Oct4), and PCNA in the ovaries. The results showed that compared with the control group, the model group exhibited disordered estrous cycles, decreased ovarian index, increased atretic follicles, and a reduced number of follicles at all stages. FSH and LH levels were significantly elevated, while AMH and E_2 levels were significantly reduced, indicating the success of the model. After treatment with Liuwei Dihuang Pills or estradiol valerate, hormone levels improved, the number of atretic follicles decreased, and the number of follicles at all stages increased. MVH marker protein and PCNA proliferative protein expression in ovarian tissue also increased. These results suggest that Liuwei Dihuang Pills regulate estrous cycles and hormone disorders in POF mice, promote the proliferation of FGSCs, improve follicular development in POF mice, and enhance ovarian function.
Animals
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Female
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Drugs, Chinese Herbal/administration & dosage*
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Mice
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Cell Proliferation/drug effects*
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Mice, Inbred ICR
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Ovary/cytology*
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Primary Ovarian Insufficiency/genetics*
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Follicle Stimulating Hormone/metabolism*
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Humans
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Anti-Mullerian Hormone/blood*
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Antineoplastic Agents/adverse effects*
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Luteinizing Hormone/metabolism*
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Cyclophosphamide/adverse effects*
7.Ursodeoxycholic acid inhibits the uptake of cystine through SLC7A11 and impairs de novo synthesis of glutathione.
Fu'an XIE ; Yujia NIU ; Xiaobing CHEN ; Xu KONG ; Guangting YAN ; Aobo ZHUANG ; Xi LI ; Lanlan LIAN ; Dongmei QIN ; Quan ZHANG ; Ruyi ZHANG ; Kunrong YANG ; Xiaogang XIA ; Kun CHEN ; Mengmeng XIAO ; Chunkang YANG ; Ting WU ; Ye SHEN ; Chundong YU ; Chenghua LUO ; Shu-Hai LIN ; Wengang LI
Journal of Pharmaceutical Analysis 2025;15(1):101068-101068
Ursodeoxycholic acid (UDCA) is a naturally occurring, low-toxicity, and hydrophilic bile acid (BA) in the human body that is converted by intestinal flora using primary BA. Solute carrier family 7 member 11 (SLC7A11) functions to uptake extracellular cystine in exchange for glutamate, and is highly expressed in a variety of human cancers. Retroperitoneal liposarcoma (RLPS) refers to liposarcoma originating from the retroperitoneal area. Lipidomics analysis revealed that UDCA was one of the most significantly downregulated metabolites in sera of RLPS patients compared with healthy subjects. The augmentation of UDCA concentration (≥25 μg/mL) demonstrated a suppressive effect on the proliferation of liposarcoma cells. [15N2]-cystine and [13C5]-glutamine isotope tracing revealed that UDCA impairs cystine uptake and glutathione (GSH) synthesis. Mechanistically, UDCA binds to the cystine transporter SLC7A11 to inhibit cystine uptake and impair GSH de novo synthesis, leading to reactive oxygen species (ROS) accumulation and mitochondrial oxidative damage. Furthermore, UDCA can promote the anti-cancer effects of ferroptosis inducers (Erastin, RSL3), the murine double minute 2 (MDM2) inhibitors (Nutlin 3a, RG7112), cyclin dependent kinase 4 (CDK4) inhibitor (Abemaciclib), and glutaminase inhibitor (CB839). Together, UDCA functions as a cystine exchange factor that binds to SLC7A11 for antitumor activity, and SLC7A11 is not only a new transporter for BA but also a clinically applicable target for UDCA. More importantly, in combination with other antitumor chemotherapy or physiotherapy treatments, UDCA may provide effective and promising treatment strategies for RLPS or other types of tumors in a ROS-dependent manner.
9.Study on Colorimetric Sensor Array Based on Enzymatic Method for Highly Selective Detection of Sarin
Lian-Bo JIANG ; Guo-Hong LIU ; Zhuang-Hu XU ; Jian LI ; Yong-Ling SHEN ; Cai-Xia XU ; Chuan-Qin ZANG ; Yan-Hua XIAO ; Dan-Ping LI ; Ting LIANG
Chinese Journal of Analytical Chemistry 2025;53(5):832-841,中插21-中插23
Sarin(GB)is a typical representative of nerve agents with high toxicity,and very low amount can cause death.GB can cause water and atmospheric environment poisoning,so the detection of GB in water and air is of great significance.In this work,a colorimetric sensor array(CSA)based on GB inhibition of cholinesterase activity was constructed to detect GB with high selectivity.A 4×4 colorimetric array was constructed using acetylcholinesterase(AChE),butyryl cholinesterase(BuChE)and the corresponding substrate acetylthiocholine iodide(S-ACh),butyryl thiocholine iodide(S-BCh),acetylcholine chloride(ACh),butyryl choline chloride(BCh)and 2,6-dichloroindophenol ethyl ester(DCIE).The linear curve of the sensor was Y=131.3×lgC+271.6(R2=0.997),where Y was the array response Euclidean distance,C was the concentration of GB(mg/L),the linear range was 0.03?0.32 mg/L,and the detection limit was 27.6 μg/L.The method could effectively distinguish chemical warfare agents(CWA)such as VX,Soman(GD),mustard gas(HD),Louie reagent(L),and had high anti-interference ability,sensitivity and good repeatability.It was successfully applied to the detection of GB in simulated water and simulated air samples,and the sample recovery rate was 97.2% ?100.9%.This method would be potentially applied to the field rapid detection of nerve agents.
10.Correlation between serum levels of LncRNA-PART1 and LncRNA-SNHG14 with disease stage,cognitive impairment and motor function in patients with Parkinson's disease
Ju GAO ; Jiajun WANG ; Xuebin XIA ; Rui WU ; Xin JIANG ; Zhanchi XIAO
International Journal of Laboratory Medicine 2025;46(8):943-947,954
Objective To investigate the correlation between serum levels of long non-coding RNA(Ln-cRNA)-prostate androgen regulated transcript 1(PART1),LncRNA-nucleolar ribonucleic acid host gene 14(SNHG14)and disease stage,cognitive impairment and motor function in patients with Parkinson's disease(PD).Methods A total of 100 PD patients(PD group)who admitted to the Department of Neurology in the hospital from January 2021 to December 2023 and 100 healthy subjects(control group)who underwent the physical examination during the same period of time were selected.According to Hoehn-Yahr staging,PD pa-tients were divided into early stage group(grade 1.0-2.5,20 cases),middle stage group(grade 3.0,48 ca-ses)and late stage group(grade 4.0-5.0,32 cases).According to the Montreal Cognitive Assessment(Mo-CA)score,the patients were divided into normal cognitive group(MoCA score≥26 points,33 cases),PD-mild cognitive impairment group(MoCA score 21-<26 points,46 cases)and PD dementia group(MoCA score<21 points,21 cases).According to the Unified Parkinson's Disease Rating Scale(UPDRS)-Ⅲ score,the pa-tients were divided into mild dyskinesia group(0-15 points,29 cases),moderate dyskinesia group(>15-40 points,46 cases)and severe dyskinesia group(>40-56 points,25 cases).Real-time fluorescence quantitative PCR was used to detect serum LncRNA-PART1 and LncRNA-SNHG14 levels.Spearman method was used to analyze the correlation between serum LncRNA-PART1,LncRNA-SNHG14 levels and Hoehn-Yahr staging,MoCA score and UPDRS-Ⅲ score in PD patients.Results The level of serum LncRNA-PART1 in PD group was lower than that in control group(P<0.05),and the level of LncRNA-SNHG14 was higher than that in control group(P<0.05).The serum levels of LncRNA-PART1 in the middle stage group and late stage groups were lower than those in the early stage group(P<0.05),and the levels of LncRNA-SNHG14 were higher than those in the early stage group(P<0.05).In addition,the serum level of LncRNA-PART1 in the late stage group was lower than that in the middle stage group(P<0.05),and the level of LncRNA-SNHG14 was higher than that in the middle stage group(P<0.05).The serum LncRNA-PART1 levels in the PD-mild cognitive impairment group and PD dementia group were lower than those in the normal cognitive group(P<0.05),while the LncRNA-SNHG14 levels were higher than those in the normal cognitive group(P<0.05).Additionally,the serum LncRNA-PART1 level in the PD dementia group was lower than that in the PD-mild cognitive impairment(P<0.05),while the LncRNA-SNHG14 level was higher than that in the PD-mild cog-nitive impairment group(P<0.05).The serum levels of LncRNA-PART1 in the moderate dyskinesia group and severe dyskinesia group were lower than those in the mild dyskinesia group(P<0.05),and the levels ofLncRNA-SNHG14 were higher than that in the mild dyskinesia group(P<0.05).In addition,the serum level of LncRNA-PART1 in the severe dyskinesia group was lower than that in the moderate dyskinesia group(P<0.05),and the level of LncRNA-SNHG14 was higher than that in the moderate dyskinesia group(P<0.05).Spearman method results showed that serum LncRNA-PART1 level was negatively correlated with Hoehn-Yahr staging and UPDRS-Ⅲ score in PD patients,and positively correlated with MoCA score(P<0.05).The level of serum LncRNA-SNHG14 was positively correlated with Hoehn-Yahr staging and UPDRS-Ⅲ score in PD patients,and negatively correlated with MoCA score(P<0.05).Conclusion The level of ser-um LncRNA-PART1 in PD patients is decreased,and the level of LncRNA-SNHG14 is increased,both of them are related to the disease stage,cognitive impairment and motor function of PD patients,which may be-come evaluation indicators for PD progression.

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